A Randomised, Double Blind, Double Observer Study to Assess Repeated Administration of a Single Dose of an Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Dose of a Trivalent Inactivated Influenza Virus Vaccine in Subjects 65 to 74 Years of Age.

NCT01701752 Phase 1 COMPLETED

This study will evaluate the safety and immunogenicity of FP-01.1 and FP-01.1 reformulated with an adjuvant (FP-01.1-Adjuvant) in relatively healthy subjects 65 to 74 years of age, subjects that are more representative of the target population. Both formulations will be administered alone or concomitantly with the Trivalent Inactivated Influenza Virus (TIV) vaccine.

Details

Lead sponsor	Immune Targeting Systems Ltd
Phase	Phase 1
Status	COMPLETED
Enrolment	120
Start date	2012-09
Completion	2013-04

Conditions

• Influenza A

Interventions

• FP-01.1 + Placebo
• FP-01.1 + TIV
• FP-01.1-Adjuvant + Placebo
• FP-01.1-Adjuvant + TIV
• Adjuvant + TIV
• Placebo + TIV
• FP-01.1
• FP-01.1-Adjuvant
• Placebo

Primary outcomes

• Number and proportion of subjects reporting solicited local reactions and severity of the local reactions — Day 1- 209
• To assess and compare the immunogenicity response between groups — Day 1- 209
  The immunogenicity of two different formulations of FP-01.1 after each vaccine injection in each treated group
• Number and proportion of subjects reporting unsolicited AEs and Serious Adverse Events (SAEs) — Day 1- 209
• Number and proportion of subjects with abnormal haematology, blood chemistry lab assessments — Day 1- 209
• Number and proportion of subjects with abnormal vital signs/ECG assessments — Day 1 - 209